BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

    K Number: K102673 · Decision Sep 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    22
    Review Days
    379

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    Basic Information

    Device Name
    RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
    K Number
    K102673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    September 16, 2010
    Decision Date
    September 30, 2011
    Product Code
    DHR
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DHR System, Test, Rheumatoid Factor

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